Ototoxicity in Patients With MoM Hip Bearings

NCT06885411 | Recruiting DMC

• 1 other identifier: OC-2021-012
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about ototoxicity in patients with a MoM hip arthroplasty. The main question it aims to answer is: • What is the prevalence of hearing loss in patients with high and low plasma metal concentrations.

Conditions

Ototoxic Hearing Loss; Cobalt Poisoning; Chromium Causing Toxic Effect; Arthroplasty Complications

Keywords

Metal-on-Metal implant; Cobalt; Chromium; Hip arthroplasty; auditory system; Otoxicity

Outcome Measures

Primary Outcomes (1)

• Mid frequency hearing loss

  Mid frequency hearing loss will be determined once with a conventional pure-tone audiometry test during a visit of the outpatient clinic

  Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.

Secondary Outcomes (5)

• Age

  Age will be determined once for each participant, at time of the visit of the outpatient clinic

• subjective general health and subjective hearing loss measured with the Amsterdam Inventory for Auditory Disability and Handicap questionnaire.

  The questionnaire will be completed once by each participant, at time of the visit of the outpatient clinic

• BMI

  Lenght and weight will be determined once for each participant, at time of the visit of the outpatient clinic

• Cobalt serum concentration

  Cobalt serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic

• Chromium serum concentration

  Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic

Study Arms (1)

Arthroplasty patients

Patients with a (revised) metal-on-metal hip arthroplasty

Other: metal-on-metal hip arthroplasty

Interventions

metal-on-metal hip arthroplasty OTHER

Cobalt and chromium release from metal-on-metal hip arthroplasties.

Arthroplasty patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.

You may qualify if:

• all MoM patients from the different clinics
• revision MoM
• willing to participate
• speak/write the Dutch language

You may not qualify if:

• Not willing to participate
• previous ENT surgery or ENT pathology

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead
• Reinier de Graaf Groep: collaborator
• Erasmus Medical Center: collaborator
• Zuyderland Medical Centre: collaborator

Study Sites (1)

Reinier de Graaf Ziekenhuis

Delft, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bloodsample to determine cobalt and chromium concentrations

Central Study Contacts

Nina Mathijssen, Dr

CONTACT

+31(0)79 206 5583; n.mathijssen@rhoc.nl

Maarten Koper, dr.

CONTACT

+31(0)79 206 5583; m.koper@rhoc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: March 20, 2025
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

NL (1)